NEWS -- Cytori Announces Japan Class III Medical Device Approval for Cell Therapy Product
Date: 12/03/2018 @ 7:30AM
Cytori Therapeutics (NASDAQ: CYTX) (“Cytori” or the “Company”) today announced that the Company has received approval for the Celution Cell Therapy System consumable bundle in Japan as a Class III medical device. The Class III designation will allow Cytori to expand its current commercial efforts in Japan and provides a clear framework for future expanded regulatory claims and reimbursement under the November 2014 PMD Act.
Furthermore, Cytori announced today that the Company has successfully outsourced an important assembly portion of the production process for its Celution Cell Therapy consumables from San Diego, CA to Viant Medical in San Antonio, Texas. The first consumable lots following this new process were shipped to customers in November 2018.
“Obtaining Class III designation follows many months of constructive interaction with the Japanese Ministry of Health, Labour and Welfare following the approval of the 2014 PMD Act,” said Marc H. Hedrick, MD, President and Chief Executive Officer of Cytori Therapeutics. “This approval coupled with the outsourced production allows Cytori to meet forecasted product demand, particularly in Japan, and better prepares us for the data read out in our Japan ADRESU pivotal trial next year.”
In Japan, Class III and Class IV medical devices require the highest levels of safety and efficacy data In Japan. These devices are also required to have special controls. Other such examples of Class III medical devices include: hemodialysis equipment, artificial bones and joints, mechanical ventilation apparatus, and balloon catheters.
Cytori currently has a fully functional logistics, sales and marketing team in Japan dedicated to commercialization of the Celution Cell Therapy System. Cytori is forecasting double digit growth in consumable utilization in Japan for 2018. Prior to the class III approval, Cytori has been selling the Celution technology mostly for aesthetic and orthopedic indications under a Class I designation.
ADRESU is an investigator-initiated, multicenter, 45 patient, open-label, single arm clinical trial of Cytori’s ECCI-50 cellular therapeutic, comprised of Celution®-prepared autologous Adipose Derived Regenerative Cells (ADRCs) and Adipose Cells for men with stress urinary incontinence as a complication of prostate intervention. A total of 45 patients, all treated in Japan, were enrolled in this potential approval trial. One-year data readout from ADRESU is anticipated in the first half of 2019.
The ADRESU trial was based on a promising pilot trial with short-term data of 11 patients published in the International Journal of Urology in 2014 and long-term data of 14 patients presented at the International Continence Society in 2017, which “demonstrated that transurethral injection of autologous ADRCs can be a safe and effective treatment modality for postprostatectomy incontinence”. Details of the ADRESU protocol and trial can be found on BMC Urology, clinicaltrials.gov and the University Hospital Medical Information Network website.
The primary endpoint for the ADRESU trial is the percentage of patients who experience greater than 50% reduction in urinary leakage volume from baseline (as measured by the weight of unintended urinary leakage over 24 hours) at 52 weeks after treatment. A number of other key secondary endpoints are also being assessed. If the primary endpoint is successfully achieved, the data may be used to seek approval of ECCI-50 for this indication.
The trial costs are substantially supported by the Japan Agency for Medical Research and Development, an independent administrative agency of the Government of Japan, with additional support from Cytori. The trial is sponsored by the lead institution, Nagoya University. About ADRESU Investigators
The ADRESU trial is being led by Dr. Momokazu Gotoh at Nagoya University, Aichi, Japan. The other participating investigators and institutes include Dr. Kazutaka Narimoto at Kanazawa University Hospital (Ishikawa, Japan), Dr. Osamu Ishizuka at Shinshu University Hospital (Nagano, Japan) and Dr. Tomonori Yamanashi at Dokkyo Medical University (Tochigi, Japan). About Male Stress Urinary Incontinence
Male stress urinary incontinence is a post-surgical complication of radical prostatectomy and surgeries for benign prostatic hyperplasia with limited treatment options, representing an unmet medical need. In 2016, the Ministry of Health, Labor and Welfare (MHLW) reported approximately 20,000 prostate cancer surgeries and 22,000 benign prostatic hyperplasia procedures performed at Diagnostic Procedure Combination (DPC) participating hospitals. About Cytori Cell Therapy™
Cytori is developing cell therapies that harness the unique attributes of adipose-derived regenerative cells (ADRCs), which are living cells that are present in an adult human’s own adipose tissue.
Cytori Cell Therapy™ is a suspension of ADRCs that are manufactured from a single lipoaspirate (material removed via liposuction, a procedure in which fat is removed from under the skin by suction). The process concentrates ADRCs intended for autologous re-implantation subcutaneously into the digits. The resultant cell suspension contains critical cells naturally occurring in the patient’s own tissue. Preparation of autologous ADRCs for subcutaneous delivery involves no cell culture and can be prepared and re-implanted into the same patient within 4 hours About Cytori Therapeutics, Inc.
Cytori is developing, manufacturing, and commercializing nanoparticle-delivered oncology drugs and autologous adipose-derived regenerative cell (ADRC) therapies within its Nanomedicine™ and Cell Therapy™ franchises, respectively. Cytori Nanomedicine™ is focused on the liposomal encapsulation of anti-neoplastic chemotherapy agents, which may enable the effective delivery of the agents to target sites while reducing systemic toxicity. The Cytori Nanomedicine™ product pipeline consists of ATI-0918 pegylated liposomal doxorubicin hydrochloride for breast cancer, ovarian cancer, multiple myeloma, and Kaposi’s sarcoma, a complex/hybrid generic drug, and ATI-1123 patented albumin-stabilized pegylated liposomal docetaxel for multiple solid tumors. Cytori Cell Therapy™, prepared within several hours with the proprietary Celution® System and administered to the patient the same day, has been shown in preclinical and clinical studies to act principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care. For more information, visit http://www.cytori.com
. Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, without limitation, conduct of clinical trials involving our technology, clinical performance, product approvals and product reimbursement, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, inherent risk and uncertainty in the protection intellectual property rights, regulatory uncertainties, risks in the conduct of clinical trials, risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, performance and acceptance of our products in the marketplace, as well as other risks and uncertainties described under the heading "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made. Investor Contact:
Cytori Therapeutics, Inc.